Company Announcements

Following FDA approval last year, Illumina's TSO Comprehensive test gains broad payer reimbursement, expanding access to comprehensive genomic profiling to match patients with targeted therapies

Illumina's IVD portfolio will also expand to offer Pillar oncoReveal^® CDx, the newest panel to deliver critical companion diagnostic testing using the Illumina MiSeq™ Dx System

SAN DIEGO , May 28, 2025 /PRNewswire/ -- Illumina Inc. (NASDAQ: ILMN) today announced an expanded clinical oncology portfolio, unlocking the next new solutions to advance precision oncology and improve the standard of care. The company's broad range of clinical offerings will accelerate access to precision oncology for more patients with cancer. Illumina tumor profiling and in vitro diagnostic (IVD) solutions will be on display at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

"Access to tumor profiling is essential to deliver on the promise of precision cancer care," said Everett Cunningham, chief commercial officer of Illumina. "With our growing portfolio of distributable clinical solutions, we are unlocking the next new standard of care for clinicians and their patients. With TSO Comprehensive and Pillar oncoReveal CDx, more labs can perform tumor profiling in-house, allowing oncologists to rapidly understand the genomic drivers of disease, and match their patients to the best possible therapies."  

Illumina TruSight™ (TSO) Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. This enables clinicians to rapidly match cancer patients with targeted therapies using comprehensive tumor profiling. Illumina customers across the US -- in community oncology care practices, regional hospitals and health systems, and academic medical centers -- are integrating TSO Comprehensive into their clinical practice. This month, UofL Health – UofL Hospital became the first Illumina customer to begin offering the test to patients.

"We are excited to bring TSO Comprehensive to our patient and provider community. Access to an in-house comprehensive tumor profiling solution will allow our care teams to deliver faster precision therapy decisions for our patients," said Mustafa Al-Kawaaz, MD, assistant professor and director of Hematology, Cytogenetics and Molecular Pathology in the Department of Pathology and Laboratory Medicine at the University of Louisville School of Medicine.

TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS), as well as most commercial health plans.

Illumina continues to pursue expanded biomarker indications and CDx claims for TSO Comprehensive in the US. Also announced today, the IVD kit has now received regulatory approval in Japan.

Illumina expands partnership with Pillar Biosciences to boost access to clinical diagnostics

Expanding its IVD portfolio, Illumina is partnering with Pillar Biosciences to offer Pillar oncoReveal CDx to Illumina customers beginning this summer. The oncoReveal CDx IVD kit is used for the detection of genetic variations in 22 genes and is intended for previously diagnosed patients with solid tumors. In April, Pillar announced that oncoReveal CDx received nationwide Medicare coverage by the CMS. 

'With over 66 million people in the US covered by Medicare, reimbursement of oncoReveal CDx will help ensure that highly accurate, actionable, and reimbursable next-generation sequencing testing is available to clinical laboratories and biopharmaceutical companies," said Brian Wright, chief marketing officer of Pillar Biosciences. "In turn, this enables faster treatment decisions and improved outcomes for everyone, everywhere."

Learn more about Illumina at ASCO and visit us at Booth 33101.

About TruSight Oncology Comprehensive

TSO Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. Comprehensive genomic profiling is a next-generation sequencing approach that uses a single assay to assess hundreds of genes—including relevant cancer biomarkers, as established in guidelines and clinical trials—for therapy guidance. TSO Comprehensive interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood that an immuno-oncology biomarker or clinically actionable biomarkers will be identified. This can open up options such as targeted therapy or clinical trial enrollment. A separate CE-marked version of TSO Comprehensive is also available in Europe.

TSO Comprehensive is FDA approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly's RETEVMO (selpercatinib).

To learn more about TruSight Oncology Comprehensive, click here.  

About oncoReveal CDx

Pillar oncoReveal^® CDx is an next-generation-sequencing-based IVD kit for the detection of SNVs, insertions, and deletions in 22 genes, intended for previously diagnosed patients with solid tumors. The kit is approved as a CDx to identify patients who may benefit from epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy (class approval) in NSCLC and ERBITUX and VECTIBIX for KRAS in CRC. oncoReveal^® CDx is FDA approved on the Illumina MiSeq Dx System.

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; and (iii) legislative, regulatory and economic developments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.

Contacts
Investors:
Brian Blanchett
IR@illumina.com

Media:
Christine Douglass
PR@illumina.com

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SOURCE Illumina, Inc.